Kirstin Borgerson explains why audiences presented with the facts in the Markingson case react with silence, and offers some thoughts on how bioethicists might break that silence.
Carl Elliott has written extensively on the case of Dan Markingson, a 26 year-old who committed suicide while enrolled in a clinical research trial, on this blog and elsewhere. A brief summary of the case, highlighting the ethical issues, is available here. Carl Elliott recently presented the latest developments in the case in a public talk at my university.
On any description, the Markingson case is worrisome, involving what appear to be violations of almost every ethical requirement of clinical research. One might expect, then, that the question period after Elliott’s talk would be lively, heated… even agitated. Not so. Nobody challenged any of Elliott’s claims or offered any contrary views. Nobody jumped up to play devil’s advocate (typically a staple of my discipline – philosophy). And this isn’t the only crowd I’ve seen have this reaction to the telling of this case. The last time I tried to teach the Markingson case to my introductory bioethics class, the class was sombre and silent; I struggled to get any kind of discussion going. Why is this?
Recall that the case involves violations not only of several standard ethical requirements of research, including social value, favourable risk/benefit ratio, and respect for subjects, but also serious violations of informed consent. Indeed, every element of informed consent is called into question in this case, including: (i) the competence of the subject to consent for himself given that he was declared incompetent several times in the days leading up to his enrolment, and, given his questionable competence, whether there could have been an appropriate level of understanding of these risks; (ii) the adequacy of disclosure to Markingson of all risks, benefits and alternatives of participation; and (iii) the voluntariness of his choice to enroll in the face of a threat of involuntary commitment. To be clear: any one of these failures would have invalidated his consent and rendered his participation in the study unethical.
It took me longer than it should have to realize why my students, and Elliott’s audiences, are so quiet when confronted with this case. Very simply, there is nothing to debate. Among serious scholars, there is no defense of the practice of: radically violating informed consent in the myriad ways just outlined; enrolling suicidal patients in the sort of risky trial that Markingson was enrolled in; having researchers disrespect and disregard concerns raised by family members about the well-being of research subjects during a trial; or creating conditions under which researchers are motivated to enroll subjects so as not to lose out on tens of thousands of dollars. My students and colleagues have it right: from an ethical perspective there isn’t anything to debate here.
This is an important case in bioethics because it reminds us just how limited ethical arguments can be, in the real world. The ‘other side’ of this case is represented not by reasoned arguments, but by legal manoeuvring and public relations. (See the latest efforts at public relations here.) There doesn’t seem to me to be much more bioethicists – or philosophically trained bioethicists – can do, if we assume that our skills lie in making clear, balanced arguments. Perhaps this is why Elliott ends his presentation of the case with a request for advice about how to proceed. The tools of our trade just aren’t enough. Like the climate change scientists who have learned that good scientific evidence carries almost no weight in the face of contrary political, economic, and social agendas, bioethicists are faced with the fact that good arguments can be ignored at will in the enterprise of clinical research.
This sounds pretty bad, and I should probably make some effort to end on a hopeful note. I think there is at least one positive lesson that derives from careful thinking about this case. Elliott mentioned that when he started looking into Markingson’s death he assumed it was a lone exceptional case. As he dug further, he realized that the problem had to be more widespread. After all, this case isn’t just about a particularly evil person doing particularly evil things, resulting in the death of a young man. It is a case about institutional failures and the ways in which those failures combined and interacted to make this death possible.
So, it seems to me that the question left for bioethicists to ask, if we want to change things within our control, is, “Could this happen at my institution?” Are research subjects in short supply, and are researchers desperate to enroll them in their trials? Are researchers motivated to enroll subjects in trials because they receive a referral fee or other (indirect) payment for doing so? How widespread are conflicts of interest among those making key decisions about clinical research? And so on. I suspect that if we ask these sorts of questions, we will find that we suddenly have a lot to talk about.
Kirstin Borgerson is Assistant Professor of Philosophy at Dalhousie University
See also Leigh Turner’s blog, University of Minnesota’s Ongoing Refusal to Investigate Allegations of Research Misconduct